Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075104
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETODOLAC | ETODOLAC | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| ETODOLAC | ETODOLAC | 500MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/06/1998 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75104.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2021 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/09/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2015 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/28/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/11/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |